Anorexia Nervosa
Conditions
Keywords
skeletal health, bone turnover, bone geometry, malnutrition
Brief summary
This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.
Interventions
DEVICELow-magnitude mechanical stimulation platform
Low-magnitude mechanical stimulation platform
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age 11-25 years * Diagnosis of anorexia nervosa based on DSM-IV criteria * Female gender * English-speaking
Exclusion criteria
* • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus * Use of medications known to affect bone metabolism in the last 3 months, such as: * Glucocorticoid therapy (including inhaled steroids) * Anticonvulsants * Combined estrogen/progestin contraceptive agents (oral contraceptive pills) * Depot medroxyprogesterone (Depo-Provera) use in the last 12 months * Current pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in C-telopeptides | Baseline to 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Bone Specific Alkaline Phosphatase | baseline to 5 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LMMS Randomized to 10 min LMMS daily | 20 |
| Placebo Randomized to sham platform 10 min daily | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Deemed ineligible after consent | 0 | 1 |
| Overall Study | Early Hospital Discharge | 6 | 4 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 8 |
Baseline characteristics
| Characteristic | LMMS | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 16.5 years STANDARD_DEVIATION 2.1 | 16.2 years STANDARD_DEVIATION 1.8 | 16.3 years STANDARD_DEVIATION 1.9 |
| BMI Z-score | -2.34 Z-score STANDARD_DEVIATION 1.6 | -3.24 Z-score STANDARD_DEVIATION 2.66 | -2.79 Z-score STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 20 Participants | 38 Participants |
| Region of Enrollment United States | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Change From Baseline in C-telopeptides
Time frame: Baseline to 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LMMS | Change From Baseline in C-telopeptides | 0.083 ng/mL/day |
| Placebo | Change From Baseline in C-telopeptides | -0.027 ng/mL/day |
Secondary
Change From Baseline in Bone Specific Alkaline Phosphatase
Time frame: baseline to 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LMMS | Change From Baseline in Bone Specific Alkaline Phosphatase | -0.07 ug/L/day |
| Placebo | Change From Baseline in Bone Specific Alkaline Phosphatase | -0.36 ug/L/day |